Medication info
Atoev Tablets 10/40 mg

Atoev Tablets 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
익수제약(주)
Appearance
White, double convex, rectangular film-coated tablets
Packaging
30 tablets/PPTP
Approval status
Active

MFDS item code 202101509 · Approved 2021.02.18

Summary

Main use
Lipid improvement by reducing cholesterol levels and increasing HDL in hypercholesterolemia and dyslipidemia.
Who uses it
Adults
Adult dosage
This drug is administered once daily regardless of meals. For the treatment of primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg per day, with an initial recommended dose of either 10/10 mg or 10/20 mg per day. If a significant reduction in LDL-cholesterol is required, an initial dose of 10/40 mg per day is recommended. Dosage adjustments should be made after verifying serum lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
익수제약(주)

Efficacy & effects

Lipid improvement by reducing cholesterol levels and increasing HDL in hypercholesterolemia and dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
View approved original text

This medication helps effectively lower total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia, including familial and non-familial hypercholesterolemia, while increasing HDL-cholesterol levels. It is also used in patients with homozygous familial hypercholesterolemia to manage total cholesterol and LDL-cholesterol levels either as an adjunct to other treatments such as LDL-Apheresis or alone. This drug is used alongside dietary therapy in treating dyslipidemia and is recommended for patients whose response to diet and other non-drug therapies is insufficient. Patients should monitor their lipid levels to confirm treatment effectiveness and treat any secondary causes (such as diabetes, hypothyroidism) if necessary. This drug may help reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia. Therefore, this medication is used in the treatment of hypercholesterolemia.

Dosage and Administration

Adult dosage

This drug is administered once daily regardless of meals. For the treatment of primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg per day, with an initial recommended dose of either 10/10 mg or 10/20 mg per day. If a significant reduction in LDL-cholesterol is required, an initial dose of 10/40 mg per day is recommended. Dosage adjustments should be made after verifying serum lipid levels at intervals of more than 2 weeks.

Precautions

This drug may cause a rare but serious adverse effect called rhabdomyolysis, which can lead to muscle damage and strain on the kidneys. Patients should immediately inform their doctor if they experience severe muscle pain or weakness, or muscle cramps. Additionally, this drug may affect liver function, hence regular liver function tests before and during treatment are necessary, and should be discontinued if any abnormal liver symptoms occur. This medication should not be administered to patients with certain liver diseases or muscle disorders, pregnant or nursing women, and those on specific medications. Care must be taken when taking this medication alongside other drugs due to potential drug interactions, particularly with medications that inhibit enzymes that metabolize drugs in the liver, as this may increase the blood concentration of this drug and the risk of side effects. Elderly patients or those with impaired renal function are at higher risk for muscle damage when taking this drug, thus extra caution is required, and they should consult a physician if symptoms occur. This drug should not be used during pregnancy as it can be harmful to the fetus, and women of childbearing age should ensure adequate contraception while on this medication. Nursing mothers are also advised to avoid this medication. Furthermore, patients should be cautious of potential symptoms like dizziness when driving or operating machinery. In case of overdose, there are no specific antidotes; treatment will require symptomatic care and support therapy, with monitoring of liver function and muscle condition. Lastly, the safety and efficacy of this drug have not been established in children, and it is not recommended for use in this population.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficult breathing, asthma attack, respiratory issues accompanied by coughing and fever, jaundice (yellowing of skin or eyes), generalized malaise, sudden and severe headaches, thunderclap headaches, seizures, altered consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • vomiting
  • diarrhea
  • joint pain
  • muscle weakness
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  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • lethargy
  • chest pain
  • chest discomfort
  • edema
  • weakness
  • headache
  • diabetic neuropathy
  • tremors
  • depression
  • upper respiratory infection
  • conjunctival congestion
  • erectile dysfunction
  • urinary tract infection
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia
  • epididymitis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. Doing so will help maintain the drug's efficacy over time.

Appearance and packaging

Appearance

White, double convex, rectangular film-coated tablets

Package unit

30 tablets/PPTP

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.